Iron DeficiencyPhase 3FER-IBD-MAINNCT00810004
Maintenance Treatment of Iron Deficiency in IBD Patients
A Phase 3 study testing Ferinject in people with Iron Deficiency and Inflammatory Bowel Disease, run by Vifor Pharma at 1 site in Russia.
Trial summary
The aim of this study is to evaluate the treatment of iron deficiency in IBD patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency, Inflammatory Bowel Disease
- What is being tested?
- Ferinject
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 245 participants
- Where
- 1 siteRussia
- Study dates
- Feb 2009to Oct 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-anaemic patients treated in the FERGI-CORRECTION study (Hb ≥12 g/dL female, ≥13 g/dL male), independent of ferritin value.
- Females of child-bearing potential must have a negative urine pregnancy test at screening and be practising an acceptable method of birth control during the study and for up to 1 month after the last dose of study medication.
Who cannot join
- Chronic alcohol abuse (alcohol consumption >20 g/day).
- Presence of portal hypertension with oesophageal varices. History of erythropoietin, intravenous or oral iron therapy, or blood transfusion in 12 weeks prior to screening.
- Known hypersensitivity to FERINJECT®.
- History of acquired iron overload.
- Myelodysplastic syndrome.
- Pregnancy or lactation.
Show all 14Show fewer
- Known active infection, clinically significant overt bleeding, active malignancy. Known chronic renal failure.
- Surgery with relevant blood loss (defined as Hb drop <2 g/dL) in the 3 months prior to screening or planned surgery within the following 3 months.
- Chronic liver disease or increase of liver enzymes (alanine aminotransferase ([ALT], aspartate aminotransferase [AST]) >3 times the upper limit of normal range.
- Known human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Inability to fully comprehend and/or perform study procedures in the investigator's opinion.
- Participation in any other interventional study (except correction study) within 1 month prior to screening.
- Body weight <35 kg.
- Significant cardiovascular disease, including myocardial infarction within 12 months prior to study inclusion, congestive heart failure NYHA (New York Heart Association) grade III or IV, or poorly controlled hypertension according to the judgment of the investigator.
Trial locations and contacts
1 site in 1 country.
Russia1 site
State Scientific Center of Coloproctology of RosMedTekhnolgy
Moscow, 123423
About this study
Official title: A Multi-centre, Randomised, Prospective, Single-blinded, Controlled Study to Investigate the Efficacy and Safety of a Standardised Maintenance Dosage Regimen of Intravenous Ferric Carboxymaltose (FERINJECT®) Versus Placebo in Patients With Iron Deficiency Caused by Inflammatory Bowel Disease
The aim of this study is to evaluate the treatment of iron deficiency in IBD patients.
- Conditions
- Iron Deficiency, Inflammatory Bowel Disease
- Being tested
- Ferinject
- Medical subject headings
- Iron Deficiencies, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FerinjectDrug
Intravenous infusion of iron
| Study group | Role | What they receive |
|---|---|---|
| Ferinject | Experimental | Intravenous infusion of iron Receives: Drug: Ferinject |
| Placebo | Placebo comparator | NaCL 0,9% Receives: Drug: Ferinject |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of maintenance treatment of iron deficiency
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startFeb 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vifor Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- Christoph Gasche, Professor, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00810004
- Sponsor's protocol ID
- FERGI-MAIN
- Acronym
- FER-IBD-MAIN
- Status last verified
- Dec 2012
- First submitted
- 16 Dec 2008
- Last updated
- 21 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Evstatiev R, Alexeeva O, Bokemeyer B, Chopey I, Felder M, Gudehus M, Iqbal T, Khalif I, Marteau P, Stein J, Gasche C; FERGI Study Group. Ferric carboxymaltose prevents recurrence of anemia in patients with inflammatory bowel disease. Clin Gastroenterol Hepatol. 2013 Mar;11(3):269-77. doi: 10.1016/j.cgh.2012.10.013. Epub 2012 Oct 16.
PubMed 23078888
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Randomised, Prospective, Single-blinded, Controlled Study to Investigate the Efficacy and Safety of a Standardised Maintenance Dosage Regimen of Intravenous Ferric Carboxymaltose (FERINJECT®) Versus Placebo in Patients With Iron Deficiency Caused by Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT00810004
- Acronym / sponsor ID
- FER-IBD-MAIN / FERGI-MAIN
- Conditions
- Iron Deficiency, Inflammatory Bowel Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Vifor PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- Feb 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 17 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the treatment of iron deficiency in IBD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferinject | Experimental | Drug: FerinjectIntravenous infusion of iron |
| Placebo | Placebo comparator | Drug: FerinjectNaCL 0,9% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Non-anaemic patients treated in the FERGI-CORRECTION study (Hb ≥12 g/dL female, ≥13 g/dL male), independent of ferritin value.
- Females of child-bearing potential must have a negative urine pregnancy test at screening and be practising an acceptable method of birth control during the study and for up to 1 month after the last dose of study medication.
Key exclusion criteria (14 listed)
- Chronic alcohol abuse (alcohol consumption >20 g/day).
- Presence of portal hypertension with oesophageal varices. History of erythropoietin, intravenous or oral iron therapy, or blood transfusion in 12 weeks prior to screening.
- Known hypersensitivity to FERINJECT®.
- History of acquired iron overload.
- Myelodysplastic syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FerinjectIntravenous infusion of iron | Drug | Ferinject, Placebo |
Primary outcome
Efficacy of maintenance treatment of iron deficiency
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2012.
- Derived from this study: PubMed 23078888Evstatiev R, Alexeeva O, Bokemeyer B, Chopey I, Felder M, Gudehus M, Iqbal T, Khalif I, Marteau P, Stein J, Gasche C; FERGI Study Group. Ferric carboxymaltose prevents recurrence of anemia in patients with inflammatory bowel disease. Clin Gastroenterol Hepatol. 2013 Mar;11(3):269-77. doi: 10.1016/j.cgh.2012.10.013. Epub 2012 Oct 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Gasche, Professor principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ferinject in people with Iron Deficiency and Inflammatory Bowel Disease, run by Vifor Pharma at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of maintenance treatment of iron deficiency (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00810004, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2012.